Comparative Physicochemical and Biological Characterisation of the Similar Biological Medicinal Product Teriparatide and Its Reference Medicinal Product
- PMID: 31595483
- PMCID: PMC6985066
- DOI: 10.1007/s40259-019-00386-x
Comparative Physicochemical and Biological Characterisation of the Similar Biological Medicinal Product Teriparatide and Its Reference Medicinal Product
Abstract
Background: In January 2017, the European Commission approved Terrosa® (company code RGB-10) as one of the first biosimilar medicinal products of teriparatide for the same indications as for the reference medicinal product Forsteo® (Lilly France S.A.S.), which has been on the market in the European Union since 2003. The active pharmaceutical ingredient of the reference medicinal product is the biologically active 1-34 fragment of the endogenous human parathyroid hormone [PTH(1-34)]. It is one of the three bone anabolic agents used in the treatment of osteoporosis promoting bone formation and preventing fragility fractures.
Objective: The objective of this paper is to summarise the results of the comparative analysis of representative batches of both the RGB-10 drug product and the reference medicinal product performed by physicochemical and in vitro biological methods.
Methods: A series of state-of-the-art analytical methods were applied in a comparative head-to-head manner for testing the similarity in respect to purity, content, structure and potency.
Results: Based on the results of the comprehensive physicochemical and biological characterisation, RGB-10 proved to be highly similar to the reference medicinal product with respect to the critical quality attributes investigated.
Conclusion: The results of the quality comparability study demonstrated similarity of RGB-10 to the reference medicinal product, providing the scientific basis for conducting a specifically designed clinical programme, and supported registration of the Marketing Authorisation Application of RGB-10 in the EU.
Conflict of interest statement
Piroska Kovács, Tamás Schäfer, Viktor Háda, Helga Hevér, Sonja Klingelhöfer, Merle Nebel, Tanja Stadie, Róbert Kiss, and Zoltán Urbányi acknowledge potential conflicts of interest as current employees of Gedeon Richter Plc. or Richter Helm Biologics GMBH & Co KG.
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References
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- European Medicines Agency. Guideline on similar biological medicinal products 2014 CHMP/437/04 Rev 1.
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- International Conference on Harmonization. Pharmaceutical development Q8(R2). 2009.
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